Blog
RSS FeedPosted by Michael Wonder on 09 Jul 2020
International regulators align positions on phase 3 COVID-19 vaccine trials
9 July 2020 - Medicines regulatory authorities from around the world have published a report today highlighting the outcomes ...
Posted by Michael Wonder on 05 Jul 2020
Oxford University is leading in the vaccine race
2 July 2020 - Governments are pouring money into a more urgent version of the space race. ...
Posted by Michael Wonder on 01 Jul 2020
International regulators provide guiding principles for COVID-19 clinical trials
1 July 2020 - EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International ...
Posted by Michael Wonder on 30 Jun 2020
EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information
30 June 2020 - EMA and the Ministry of Food and Drug Safety of the Republic of Korea have signed ...
Posted by Michael Wonder on 25 Jun 2020
First COVID-19 treatment recommended for EU authorisation
25 June 2020 - EMA’s human medicines committee has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the ...
Posted by Michael Wonder on 18 Jun 2020
International regulators stress value of safe and effective vaccines
18 June 2020 - EMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the ...
Posted by Michael Wonder on 16 Jun 2020
First drug proves able to improve survival from COVID-19, trial shows
17 June 2020 - A low-cost, widely used anti-inflammatory drug has improved survival in patients with COVID-19, scientists say, the ...
Posted by Michael Wonder on 15 Jun 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4
15 June 2020 - The International Coalition of Medicines Regulatory Authorities convened its regular virtual meeting of regulators from around ...
Posted by Michael Wonder on 14 Jun 2020
EMA management board backs rolling review fees, COVID-19 transparency measures
12 June 2020 - After its June meeting on Thursday, the EMA’s management board said it has approved a new ...
Posted by Michael Wonder on 08 Jun 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #7
8 June 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 08 Jun 2020
EMA receives application for conditional authorisation of first COVID-19 treatment in the EU
8 June 2020 - EMA has now received an application for conditional marketing authorisation of the antiviral medicine remdesivir for ...
Posted by Michael Wonder on 04 Jun 2020
Patients’ and health care professionals’ organisations updated on EMA’s response to COVID-19
4 June 2020 - EMA updated patients’ and healthcare professionals’ organisations about its COVID-19 activities. ...
Posted by Michael Wonder on 03 Jun 2020
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...
Posted by Michael Wonder on 31 May 2020
COVID-19: reminder of the risks of chloroquine and hydroxychloroquine
29 May 2020 - The EMA is reminding health care professionals to closely monitor patients with COVID-19 who are receiving ...
Posted by Michael Wonder on 31 May 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
28 May 2020 - As part of its coordinated response to the pandemic, the International Coalition of Medicines Regulatory Authorities ...